Arrow International Inc
9 French Super Arrow-Flex Percutaneous Sheath Introducer Kit with Arrowg and Blue Antimicrobial Surface Sheath
| Date | Jul 19, 2003 (initiated Jul 8, 2003) |
| Status | Terminated |
| Reason | separation of sheath |
| Root cause | Other |
| Action | The recalling firm issued recall letters dated 7/9/03 to their accounts informing them of the problem and the need to return the product. To expedite product removal the recalling firm telephoned the accounts that received the complaint lot. |
| Quantity | 13442 units |
| Distribution | The products were shipped to hospitals, distributors, dealers and sales representatives nationwide. The product was also shipped to export dealers in Finland, Australia, Italy, Brazil, Taiwan, New Zealand, Poland, United Kingdom, and Belgium and subsidiaries in Germany, France, Africa, Canada, Nethe |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K940079 | ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903 Arrow Intl., Inc., Nov 30, 1994 |